Epidural Loading: High Volume, Low Concentration

Ohio State University

Overview

This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter. Control patients will receive local anesthetic in lower volume more concentrated solution via the epidural catheter which is current standard practice. Outcome measures will include quantifying pain relief with respect to time using VAS scores. In addition, post delivery patient satisfaction regarding anesthesia regimen, blood pressure changes, heart rate, anesthetic level, total dose of epidural used during labor, rescue doses and incidence of fetal bradycardia will be assessed. 35 patients will be recruited for each of the three arms of the study, totaling 105 patients, in order to obtain significance when performing statistical analyses following complete enrollment in the study. The impetus of this study involves investigation of the effects of loading the epidural space with high volume, low concentration local anesthetic via two different modalities and studying which method is more efficacious.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Labor and Delivery

Interventions

Epidural needlePROCEDURE

Medication administration via epidural needle.

Catheter AdministrationPROCEDURE

Medication administration via epidural catheter.

Standard of Care Epidural AdministrationPROCEDURE

Medication administered at higher concentration, lower volume via epidural catheter.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects who have volunteered and consented to participation in the study upon admission to labor and delivery 2. Parturients in active labor requesting epidural analgesia 3. Uncomplicated pregnancy with a reassuring fetal heart tracing 4. Age greater than or equal to 18 years Exclusion Criteria: 1. Contraindication to epidural anesthesia 2. Inability to read, comprehend, and sign the informed consent form 3. Fetal intrauterine growth retardation (IUGR) 4. Non-reassuring fetal heart tracing 5. Cervical dilation greater than 7cm 6. Intra-uterine fetal demise 7. History of chronic pain other than in the back 8. Incarcerated patients I. Any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (\>3 attempts, presence of CSF) j. Any evidence of high spinal after initial bolus or continuous infusion of high volume, low concentration local anesthetic solution k. Women undergoing cesarean section

Locations (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Patient Pain Levels (VAS Assessment)

Patients will be assessed for pain levels on the VAS scale after analgesia administration in both arms

Time frame: During Labor

Patient Satisfaction

Patient satisfaction with analgesia using a Likert rating of patient satisfaction with anesthetic care.

Time frame: During labor

Secondary Outcomes

Analgesic level

Pinprick every 10, 15, and 20 minutes following loading

Time frame: 20 minutes

Maternal Vital Signs

Measure change in maternal blood pressure and heart rate over 20 minutes following loading.

Time frame: 20 minutes

Fetal Heart Rate

Measure change in fetal heart rate following loading.

Time frame: 20 minutes

Rescue Bolus

Measure number of rescue bolus doses and total anesthetic dose

Time frame: During Labor

Intravascular Catheter Placement

Measure incidence of intravascular catheter placement.

Time frame: During labor

Data from ClinicalTrials.gov

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